MAUDE Adverse Event Report: NIPRO (THAILAND) CORP. LTD. MONOJECT 12ML SYRINGE

Model Number	1181200777T
Medical Device Problem Code	Material Disintegration (1177)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation report attached is on retained samples by the manufacturer only.Pending return of samples from customer for further investigation.
Event or Problem Description
The customer reported that the 12ml syringe has residuals after the infusion of the medication.Other syringes so far had no issues with residuals before but a few months ago they had the same issue with 12mls.They are not sure if it is the syringe or the pump that is causing the residuals.Additional information received on 27dec2024 stated that the staff in nicu has noted that only the 12ml syringe of iv medication has residuals.This syringe is not coming from the nicu bb but from pharmacy as the medication comes prefilled from them.This 12ml medication syringe is only being used in the pump during medication administration.The pump being used is the braun infusomat syringe pump - no other issues with other syringe infusion.The usual medication infused on the 12ml in their unit is gentamicin.Amount of medication varies with each weight specific dose but residuals seems to be consistent between 1-1.5ml.The pump indicates that the infusion has been completed.There was no harm to the patient but staff needs to override and re-infuse the remaining dose/ push residual through tubing extension set before infusing the saline to flush medication extension tubing.
Additional Manufacturer Narrative
Investigation report attached is on retained samples by the manufacturer only.Pending return of samples from customer for further investigation.03/21/25: customer did not return any samples.Final investigation is on retained representative lots since lot number for the reported product was unknown.
Event or Problem Description
The customer reported that the 12ml syringe has residuals after the infusion of the medication.Other syringes so far had no issues with residuals before but a few months ago they had the same issue with 12mls.They are not sure if it is the syringe or the pump that is causing the residuals.Photos attached.Additional information received on 27dec2024 stated that the staff in nicu has noted that only the 12ml syringe of iv medication has residuals.This syringe is not coming from the nicu bb but from pharmacy as the medication comes prefilled from them.This 12ml medication syringe is only being used in the pump during medication administration.The pump being used is the braun infusomat syringe pump - no other issues with other syringe infusion.The usual medication infused on the 12ml in their unit is gentamicin.Amount of medication varies with each weight specific dose but residuals seems to be consistent between 1-1.5ml.The pump indicates that the infusion has been completed.There was no harm to the patient but staff needs to override and re-infuse the remaining dose/ push residual through tubing extension set before infusing the saline to flush medication extension tubing.

• Brand Name: MONOJECT 12ML SYRINGE
• Common Device Name: SYRINGE
• Manufacturer (Section D): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8; bangnomko,; sena, ayuthaya 13110 ,; TH 13110,
• Manufacturer (Section G): NIPRO (THAILAND) CORP. LTD.; 10/2 moo 8; bangnomko,; sena, ayuthaya 13110 ,; TH 13110,
• Manufacturer Contact: michelle tejada ; 3150 nw 107th avenue; miami, FL 33172 ; 3055997174
• MDR Report Key: 21339814
• Report Number: 8041145-2025-00002
• Device Sequence Number: 14409517
• Product Code: FMF
• UDI-Device Identifier: 10884521179233
• UDI-Public: 10884521179233
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K130049
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1181200777T
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 02/07/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown